Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
Medtronic v. Lohr is a foundational Supreme Court case at the intersection of products liability and federal preemption under the Food, Drug, and Cosmetic Act's Medical Device Amendments (MDA).
Does 21 U.S.C. § 360k(a) of the Medical Device Amendments preempt state common-law claims (such as negligent design, negligent manufacturing, and failure to warn) against a medical device manufacturer when the device was cleared through the FDA's §510(k) substantial equivalence process rather than the PMA process?
Under the MDA's express preemption clause, 21 U.S.C. § 360k(a), a state may not establish or continue in effect any requirement with respect to a medical device that is different from, or in addition to, federal requirements and that relates to the device's safety or effectiveness. Preemption applies only if: (1) the FDA has established specific federal requirements applicable to the particular device, and (2) the state-law duty would impose a requirement different from, or in addition to, those federal requirements. State-law claims that parallel federal requirements (i.e., impose duties "equal to, or substantially identical to," federal obligations) are not preempted. The §510(k) process, which turns on substantial equivalence rather than a device-specific safety/effectiveness approval, generally does not impose device-specific federal requirements that trigger preemption.
State common-law claims challenging the design, manufacture, and labeling of a §510(k)-cleared medical device are not categorically preempted. Design-defect and failure-to-warn claims were not preempted because §510(k) clearance does not impose device-specific federal requirements, and any manufacturing or labeling claims that parallel federal requirements may proceed. The Court affirmed in part, reversed in part, and remanded for consideration of whether any particular claims would impose requirements different from, or in addition to, applicable federal obligations.
Lohr is the cornerstone of medical-device preemption jurisprudence for §510(k)-cleared products. It preserves state tort remedies by holding that §510(k) clearance generally does not trigger broad express preemption and by recognizing the viability of parallel claims. For practitioners, it establishes a roadmap: plaintiffs may plead state duties that mirror federal requirements (e.g., alleging violations of FDA regulations), while defendants may invoke preemption against state rules that would add to or differ from federal obligations. For students, Lohr is essential background to later Supreme Court cases: Buckman (2001), which found implied preemption of fraud-on-the-FDA claims, and Riegel (2008), which held that PMA-approved devices are broadly protected by express preemption, thereby sharpening the contrast with §510(k)-cleared devices.